Last updated on September 2018

Study of Progesterone in Treatment of Vasomotor Symptoms

Brief description of study

The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be tested against placebo in hierarchical order, starting with the highest dose. Superiority will be defined as a significant (significance level = 0.05) reduction of moderate to severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint of the study).

Clinical Study Identifier: NCT03202186

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Fach rztin f r Gyn kologie und Geburtshilfe
Bernburg, Germany
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Recruitment Status: Open

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